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510(k) K082430

SYNGO IMAGING XS by Siemens AG Medical Solutions — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2008
Date Received
August 22, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K120331 — SYNGO CT DYNAMIC ANGIO (April 13, 2012)
  • K111079 — SYNGO.VIA WEB VIEWER (May 13, 2011)
  • K101666 — SYNGO. PLAZA VA20A (August 10, 2010)
  • K100637 — SYNGO.CT CORONARY ANALYSIS (May 26, 2010)
  • K093612 — SYNGO.PLAZA (March 4, 2010)
  • K092067 — ABVS WORKPLACE (September 18, 2009)
  • K092519 — SYNGO.X (August 27, 2009)

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